A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

Completed

Conditions studied: Herpes Zoster

In brief

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

Key facts

Study ID

NCT03563183

Run by

GlaxoSmithKline

People needed

26976

Starts

2018-06-05

Expected to finish

2019-04-30

Last updated by the study team

2020-04-30

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects who participated in the Zoster 006 and Zoster 022 trials.
• Subjects who died or were lost to follow-up during ZOSTER-006 and ZOSTER-022 will be considered for enrolment in ZOSTER-064 and their data/questionnaires up to that point will be used.

You may not qualify if…

• Subjects who were excluded from all analyses from ZOSTER-006 and ZOSTER-022. This will include any subject eliminated following deviations from GCP compliance.
• Subjects who developed a suspected HZ case during ZOSTER-006 and ZOSTER-022 (since their QoL questionnaires were encoded in the eCRF for ZOSTER-006 and ZOSTER-022).

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Meridian, Idaho, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Cary, North Carolina, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Hickory, North Carolina, United States
• GSK Investigational Site — Mt Pleasant, North Carolina, United States
• GSK Investigational Site — Salisbury, North Carolina, United States
• GSK Investigational Site — Wilmington, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Beachwood, Ohio, United States
• GSK Investigational Site — Wadsworth, Ohio, United States
• GSK Investigational Site — Pleasant Hills, Pennsylvania, United States
• GSK Investigational Site — Uniontown, Pennsylvania, United States
• GSK Investigational Site — Greer, South Carolina, United States
• GSK Investigational Site — Bristol, Tennessee, United States
• GSK Investigational Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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